Concomitant medical product: arctic front advance cardiac cryoablation catheter.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The overall baseline gender/age characteristics is male/57 years old.The model represented in this report is a representative of possible models involved.Models could include the sheath - flexcath or flexcath advance, and the cryoballoon catheter - arctic front or arctic front advance.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿long-term outcomes of cryoballoon pulmonary vein isolation for paroxysmal and persistent atrial fibrillation in chinese patients.¿ doi: 10.1007/s10840-019-00542-x published online; ahead of print.Journal of interventional cardiac electrophysiology.2019.If information is provided in the future, a supplemental report will be issued.
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The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system: there was a total of eight (8) patients who experienced transient or persistent phrenic nerve palsy (pnp); with unknown treatment/resolution.There was one (1) patient who had cardiac tamponade; with unknown treatment/resolution.There was one (1) patient who had deep vein thrombosis; with unknown treatment/resolution.There were two (2) patients who had femoral pseudoaneurysms; with unknown treatment/resolution.Three (3) patients had hemoptysis, and three (3) patients had neck hematomas; all with unknown treatment/resolution.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers.The status/disposition of the cryoablation system is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.
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